A Study to Assess the Feasibility of an E-Health System (ZEMY) Designed to Manage Symptoms in Participants With Breast Cancer Under Anti-Cancer Treatment

NCT03558490 | Completed Phase 2

• 1 other identifier: ML39208
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 5

Brief Summary

This is a three-month open-label, multicenter, interventional, single arm study located in France, designed to assess feasibility and reliability of the e-Health ZEMY software medical device under investigation for use by participants with breast cancer, who are starting an anti-cancer treatment at any stage of the disease, to manage disease symptoms and anti-cancer treatment-related toxicities while at home.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Who Successfully Use ZEMY

  A participant will be considered as successful in terms of the feasibility of using ZEMY if she has completed at least three symptom reported connections and if the rate of completed symptom reported connections for this participant is ≥ 60%.

  3 months

Secondary Outcomes (15)

• Percentage of Appropriate Automatic Messages and Recommendations for Each Symptom by ZEMY, as Evaluated by the Investigator at Each Visit

  At Weeks 3, 6, 9, and 12 (Up to 3 months)

• System Usability Scale Score, Rated by Participants and Healthcare Professionals (HCPs)

  At 3 months

• Satisfaction with ZEMY, Assessed on a Visual Analog Scale by Participants and HCPs

  At 3 months

• Percentage of Participant Answered Entries per ZEMY Requests for Solicited Symptom Information

  3 months

• Number of Automatic Messages Generated by ZEMY per Participant Over the Study Period

  3 months

Study Arms (1)

ZEMY software

EXPERIMENTAL

Device: ZEMY software; Drug: Investigator's choice of anti-cancer treatment (except immunotherapy)

Interventions

ZEMY software DEVICE

The ZEMY software medical device integrates specific algorithms based on international and validated guidelines. It provides individually customized information and defines for the patient an adapted action to follow for each of the following reported symptoms or anti-cancer treatment-related toxicities: diarrhea, fatigue, nausea, vomiting, cutaneous and mucosal toxicities, pain, fever/febrile neutropenia, high blood pressure, anxiety and depression. During the 3-month study period, participants will be asked to enter their symptoms among the 10 symptoms listed in ZEMY on their smartphone dedicated to the study. Consequently, ZEMY software will provide to the participants adapted real-time information to advise them on the management of the experienced symptom and recommend hygienic-dietetic advice and symptomatic treatments.

ZEMY software

Investigator's choice of anti-cancer treatment (except immunotherapy) DRUG

All anti-cancer treatments (except immunotherapy) will be left to the free choice of investigators. Participants shall be prescribed by the healthcare team both of the following symptomatic treatments: loperamide or any other anti-diarrheic treatment in case of diarrhea; and a prescription for any medication indicated in case of nausea/vomiting. A written prescription will be made by the investigator at screening for loperamide or any other anti-diarrheic treatment and symptomatic treatment for nausea/vomiting with documented dosage and duration.

ZEMY software

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients with breast cancer starting a treatment including oral and/or parenteral anti-cancer drugs (chemotherapy and/or targeted therapies, hormonotherapy)
• Inter-cycle duration between hospital visits ≥14 days (this period of time is estimated to be consistent with a need for support during the home setting period)
• Patients shall be prescribed loperamide or any other anti-diarrheic treatment in case of diarrhea and prescription for any medication indicated in case of nausea/vomiting
• Able to speak and read French and to use a smartphone embedding ZEMY, in the investigator's judgment
• Able to comply with the study protocol, in the investigator's judgment
• Patient affiliated to the national social security or beneficiary to such insurance.

You may not qualify if:

• Pregnant
• Already enrolled in a clinical study involving experimental medication or eHealth device
• Concomitant malignancy
• ECOG score \>2
• Treated with single hormonotherapy, single surgery or single radiotherapy, immunotherapy.
• Patient whose mental state renders her unable to understand the nature, purposes, and consequences of the study
• Patient not trained to the use of ZEMY
• Patient not trained to take her blood pressure measurement
• Patient deprived of her liberty by judicial or administrative order.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (5)

Centre Francois Baclesse; Oncologie

Caen, 14076, France

Location

Centre Jean Perrin; Oncologie

Clermont-Ferrand, 63011, France

Location

Hopital Prive Jean Mermoz; Cancerologie

Lyon, 69373, France

Location

Hopital Saint Louis; Oncologie Medicale

Paris, 75475, France

Location

Institut du Cancer Coulancy Reims

Reims, 51100, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2018
• First Posted: June 15, 2018
• Study Start: June 12, 2018
• Primary Completion: April 19, 2019
• Study Completion: April 19, 2019
• Last Updated: July 22, 2019

Record last verified: 2019-07

Locations

FR (5)